LINCOLN, Neb.—Celerion, a provider of early-stage drug
development
solutions, and Ricerca Biosciences, a drug-safety assessment
specialist, have formed the Biosimilars
Alliance, which will focus on
preclinical and early clinical assessment of biologics manufactured by a new
supplier.

The two new partners have long operated as "sister
companies," says Celerion's vice president of global bioanalytical
services,
Dr. Raymond Farmen, with Ricerca's CEO Ian Lennox also serving as chairman of
the board at Celerion. The formation of the new alliance was
driven by "client
demand for an integrated service solution for the development of biosimilar
products," the companies claim, but also quite probably
by the existing level
of uncertainty about regulatory issues. The goal will be to bridge the gap
between newly sourced products and patient studies.

The market for biosimilars is forecast to grow from $2.4
billion in 2012 to $44 billion by 2020.
While there has been an established
pathway for the approval of biosimilar products in Europe for several years,
the U.S. Food and Drug Administration has only recently issued its guidances.
And
the process is not likely to be as simple as some may envision.

For example, Farmen cites a study
where no GMP analytical
differences could be found between batches but PK studies in mice revealed
completely different efficacy profiles, with two
batches failing completely
while two others presented good concentration curves. Also, Farmen notes the
importance of determining if the assay is for
free drug or total drug when you
are developing the bioanalytical assay.

"You need to develop a
strategy upfront for developing
assays," he says, because large molecule biosimilars are likely to result in
more variability.

The Biosimilars Alliance will offer access to all of the
specialized services required to perform early assessment
of the viability of a
potential biosimilar product before beginning costly multicenter comparator
studies in the target patient populations. These
services include in-vitro and in-vivo pharmacological assessments of activity and toxicological and
immunotoxicological studies to
support CTAs and INDs. The alliance also
provides access to bioanalytical assay development to enable pharmacokinetic
(PK) and pharmacodynamic (PD)
assessments in animal and human studies, PK/PD
modeling, immunogenicity screening during clinical studies and the regulatory
and integrated project
management support to ensure timely results for
strategic decision-making.

"The announcement of the
Biosimilars Alliance demonstrates
Celerion's ability to respond to client needs and offer effective solutions
that leverage the knowledge base built
up over the past 20 years of supporting
biologic drug development," says Dr. Susan Thornton, president and CEO of
Celerion. "The formation of the
Biosimilars Alliance is consistent with
Celerion's goal of providing fully integrated services to get to go/no-go
decisions quickly."

"Ricerca Biosciences is well-positioned in Europe, Asia and
North America to enhance the success of the
Biosimilars Alliance. Biosimilars
are a rapidly growing segment of the market, and we see increasing demand from
our clients for safety and efficacy
testing to assess viability," says Lennox.
"The Biosimilars Alliance is an important step for Ricerca in supporting the
future needs of our clients.
"

Farmen emphasizes that the alliance is based on the
long-term working relationship between the
two companies, and there are no
contracts between the two, nor any exclusivity.

"We trust each other,
" he says.

Celerion provides early-stage clinical research solutions
from facilities strategically
located around the world, with more than 730 beds
in Phases I and IIa, NDA-enabling clinical pharmacology, ADME, clinical
pharmacology sciences, global
bioanalytical services (discovery through
late-stage) and drug development services. Sister company Ricerca Biosciences
offers a suite of discovery,
preclinical and development services to support
drug candidates from discovery through IND and NDA on a global scale.

Capabilities include
molecular through in-vivo screening and profiling, medicinal chemistry,
IND-enabling toxicology, API process chemistry and cGMP manufacturing of
clinical and commercial API. It operates out of U.S.-based facilities in
Concord, Ohio, and Bothell, Wash., and ISO 9001-certified facilities in
Taipei,
Taiwan, and Lyon, France. The Lyon and Concord facilities hold AAALAC
certification.